Evaluation of the Epilepsy-related Quality of Life, Seizure-related Accidents and Validation of the Mjn-SERAS Solution in the Normalised Patient Environment with Real-World Data

Launched by MJN NEUROSERVEIS, S.L · Apr 25, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how a medical device called mjn-SERAS can help improve the quality of life for people with epilepsy who do not respond to standard treatments. The study aims to see if this device can detect seizures earlier and provide alerts about one minute before a seizure happens. Researchers will be gathering information from 130 participants aged 12 to 65 who have been diagnosed with epilepsy and experience seizures during the day. To participate, individuals must have a confirmed diagnosis of drug-resistant epilepsy and experience a minimum number of seizures each month.

Participants in this study can expect to use the mjn-SERAS device in their daily lives and report on their experiences. The trial is currently recruiting and will take place in various centers, allowing researchers to gather real-world data about how effective the device is in a normal environment. It's important for potential participants to know that this study focuses solely on certain types of seizures, and those with specific conditions or types of seizures may not be eligible.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Age criterion:
• • o Patient must be 12 to 65 years of age inclusive, at the time of signing the informed consent.
• * Clinical criteria:
• • Confirmed diagnosis of drug-resistant\*1 epilepsy, with focal, generalized or focal -generalized seizures, according to international standards from ILAE 2017 classification\*2 (link), who will be evaluated by a specialised epilepsy unit and who are expected to have seizures.
• • The video-EEG records of patients must have epileptic seizures counted and recorded by specialised clinical personnel through accepted and contrasted gold-standard systems\*3 or evaluated by a specialized epilepsy unit and expected to experience seizures with electroclinical manifestations If there are clear clinical epileptic seizures (e.g. motor seizures), patients could be involved even without v-EEG records, according to medical criteria.
• • Patients with a clinical history and previous video-EEG records that allows certainty about the diagnosis and characteristics of the participant's epilepsy. If there are clear clinical epileptic seizures (e.g. motor seizures), patients could be involved even without v-EEG records, according to medical criteria.
• • Precise semiological information on the patients included.
• • Patients with both sides localisation will be accepted, and the wearable device will be placed in the side that is most evident the origin of the seizures, to be placed as near as possible to the focal point.
• • Presence of more than 10 day seizures per year, from tonic, tonic-clonic, clonic or atonic seizures, and a minimum of 2 to 4 day seizures per month (preferably 4 per month/ 1 per week) during the last 3 months, reported by the patients/caregivers or assessed by the neurologist through the patient history. The patient must have seizures during the day to record them, not just seizures at night.
• • Patients included in ICD-10\*4 and ICD-10-GM\*5 classification as G40 with electroclinical manifestation of seizures.
• • G40.1 Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple focal seizures
• • G40.2 Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex focal seizures
• • G40.3 Generalized idiopathic epilepsy and epileptic syndromes
• • G40.6 Grand mal seizures, unspecified (with or without petit mal). According to medical criteria and electroclinical seizure manifestations (focal, focal-generalized or generalized onset seizure with a normal interictal EEG recording).
• • G40.8 Other epilepsies (Epilepsies and epileptic syndromes, undetermined whether focal or generalized). According to medical criteria and electroclinical seizure manifestations (focal, focal-generalized or generalized onset seizure with a normal interictal EEG recording).
• • o In case of epileptic syndromes not listed in the above or shows some of the syndromes mentioned in the exclusion criteria, patients could be included according to medical criteria defined by the clinician. These criteria must be accordingly justified by the clinician ( e.g., focal or generalized onset seizures without encephalopathy and with a normal interictal EEG recording).
• * Technological criteria:
• • Ability to navigate in Android or iOS operating system. If mild or moderate disability, family members can assist with navigation if patient is unable. The smartphone must stays with the patient to record EEG, but seizures are registered by a family member.
• • Exclusion criteria
• • Presence of psychogenic seizures.
• • If there is a coexistence of epileptic and non-epileptic seizures, it will be considered an exclusion criterion if the patient or family cannot differentiate between the two types of seizures.
• • If the patient or family can always differentiate between the two types of seizures, the patient could be included in the study according to medical criteria (but only recording the epileptic seizures.)
• • Psychiatric, neurological, or systemic disorders that the researcher believes could affect the realisation and interpretation of the results.
• • Presence of more than 10 seizures per day on a habitual basis.
• • Presence of epilepsia partialis continua (G40.5\*4\*5)
• • Patients with legal representative
• • Pregnant women
• • Patients with only absence seizures (G40.A\*4,G40.4\*5)
• • Patients with only myoclonic seizures or epileptic spasms (G40.B\*4,G40.4\*5).
• • Patients included in ICD-10\*4 and ICD-10-GM\*5 classification and not included in the medical criteria for specific epileptic syndromes in inclusion criteria.
• • G40.0 Localization-related (focal)(partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset
• • G40.4 Other generalized epilepsy and epileptic syndromes. In case of specific epileptic syndromes, patients could be included according to medical criteria (e.g., focal or generalized onset seizures without encephalopathy and with a normal interictal EEG recording)
• • G40.5 Epileptic seizures due to external causes\*4 or Special epileptic syndromes\*5
• • G40.7 Petit mal, unspecified, without grand mal seizures
• • G40.9 Epilepsy, unspecified
• • Participants in previous clinical trials with mjn-SERAS device.
• • In the case the patient presents an epileptic syndrome mentioned in the exclusion criteria, the patient if the clinician considers the subject meets medical criteria to be included, the patient can be enrolled in the study. These criteria must be accordingly justified by the clinician (e.g., focal or generalized onset seizures without encephalopathy and with a normal interictal EEG recording